Write to us. Reduces risk of regulatory rejection due to poorly designed studies.
Under Regulation (EU) 2017/746 (IVDR), manufacturers must establish sufficient analytical and clinical performance evidence in the intended-use population. A study must be designed to verify diagnostic accuracy of the test through direct comparison to validated reference methods and to demonstrate analytical robustness across relevant specimen matrices and operational variables.
IVD Performance Evaluation
IVD Performance evaluation is a mandatory requirement for all IVD devices. The regulation is clear that manufacturers must demonstrate three pillars of performance:
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Scientific Validity – association between the analyte and the clinical condition.
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Analytical Performance – ability of the IVD to correctly detect/measure the analyte.
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Clinical Performance – ability of the IVD to yield results correlated with a particular clinical condition or physiological state.
The exact tests depend on the type of IVD (e.g., molecular, immunoassay, self-test, companion diagnostic), but IVDR Annex I (GSPR 9–13) outlines minimum mandatory parameters:
Analytical Performance Tests:
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Accuracy (trueness & precision)
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Analytical sensitivity (limit of detection)
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Analytical specificity (cross-reactivity, interference)
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Trueness of measurement
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Precision (repeatability, reproducibility, intermediate precision)
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Limits of detection, quantitation, measuring range
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Linearity
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Cut-off values (if applicable, e.g., qualitative tests)
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Carry-over
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Stability (specimen, reagent, calibrator, control materials)
Clinical Performance Tests:
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Diagnostic sensitivity (true positive rate)
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Diagnostic specificity (true negative rate)
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Positive predictive value (PPV) & Negative predictive value (NPV)
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Likelihood ratios
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Expected values in normal/affected populations
When a CRO is Mandatory / Highly Recommended
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Prospective clinical performance studies with patient samples, CRO involvement is almost unavoidable because you need ethics committee submission, informed consent, study site management, and monitoring and CROs ensure compliance with ISO 20916 and GCP.
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Multicenter or international trials CROs manage coordination, logistics, and standardized data collection.
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High-risk IVDs (Class C & D) Notified Bodies expect independent, unbiased data. Manufacturer-led studies without third-party oversight often face credibility issues.
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Lack of in-house clinical research infrastructure If the manufacturer cannot demonstrate expertise in study management, monitoring, and data handling, outsourcing to a CRO becomes necessary.
Reghelps SRC CRO Service Scope covering IVD devices
A CRO (Contract Research Organization) can be a major asset for completing IVD performance evaluations under both EU IVDR and US FDA regulations. Here’s a detailed breakdown:
IVD Performance Evaluation Related FAQ’s
Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.
Our services cover:
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UDI-DI and UDI-PI structure guidance
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Compliance with GS1, HIBCC, or ICCBBA issuing agencies
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UDI label and packaging review
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Preparation for EUDAMED UDI/Device registration module
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UDI-related documentation for your Technical File and CE submission
By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.
Based on the number of models and varients the timeline may change. usually the timeline for class B is approx 8-10 montsh and Class D is 14 months.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
No. Human Factors studies complement but do not replace clinical evaluation. They specifically assess device-user interaction, whereas clinical evaluation assesses clinical performance, safety, and benefits.
Absolutely. In addition to EC REP services, we offer end-to-end regulatory consulting, including Notified Body selection, technical file preparation, and gap analysis to support your CE Marking journey efficiently.
